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Methotrexate in rheumatoid arthritis. A five-year prospective multicenter study

M E Weinblatt¹, H Kaplan, B F Germain

¹Brigham and Women's Hospital, Boston, Massachusetts 02115.

Arthritis and Rheumatism

|October 1, 1994

Summary

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Long-term oral methotrexate (MTX) significantly improved rheumatoid arthritis (RA) symptoms and function over 5 years. Most patients maintained treatment with acceptable tolerability, demonstrating sustained efficacy.

Area of Science:

Rheumatology
Clinical Pharmacology
Immunology

Background:

Rheumatoid arthritis (RA) is a chronic autoimmune disease requiring long-term management.
Oral methotrexate (MTX) is a common treatment for RA, but long-term efficacy and tolerability data are crucial.

Purpose of the Study:

To assess the long-term (5-year) efficacy and tolerability of oral methotrexate in patients with rheumatoid arthritis.
To evaluate sustained clinical response and functional status improvements with continuous MTX treatment.

Main Methods:

A 5-year prospective study involving 123 patients with RA who previously completed a 9-month trial.
Patients continued treatment with oral methotrexate (MTX).
Clinical disease variables, functional status, and Westergren erythrocyte sedimentation rate (ESR) were monitored.

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Main Results:

Significant improvements were observed in clinical disease variables, functional status, and ESR (P = 0.0001) compared to baseline.
Marked improvement in joint pain/tenderness (71%) and swelling (69%) was noted.
64% of patients completed the 5-year study while on MTX, with an acceptable toxicity profile.

Conclusions:

Long-term oral MTX treatment in RA demonstrates sustained clinical efficacy and functional improvement.
The Westergren ESR also showed sustained improvement.
The study confirms an acceptable toxicity profile for long-term oral MTX use in RA management.